Three-dimensional (3-D) printing, which involves the construction of physical objects from digital models, may revolutionize surgical care. By using computer-aided design based on computed tomographic images or laser surface scans, clinicians can more precisely tailor therapeutics, implants, and potentially soft tissue and organs for the specific anatomy of each patient. For example, in 2013, researchers reported the successful printing and implantation of a customized, bioresorbable tracheal splint for the treatment of an infant with tracheobronchomalacia.
With the US Food and Drug Administration (FDA) expected to issue guidance on 3-D printing in the coming year, we believe it is an opportune time to examine key issues relating to the clinical use, regulation, and reimbursement of this novel technology. In our article, we examine key issues relating to the clinical use, regulation, and reimbursement of 3-dimensional printing technology. We argue that by coupling a flexible risk-based regulatory framework with novel reimbursement policies designed to encourage collection of long-term clinical data, clinicians and policymakers may better balance stimulating continued innovation in this field with the need to ensure the safety and effectiveness of personalized medical devices.
(cite: Hwang TJ, Kiang CJ, Paul M. Surgical applications of three-dimensional printing and precision medicine. JAMA Otolaryngol Head Neck Surg 2015: 141(4): 305-306.)